Label: CITROMA- magnesium citrate liquid 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/12

If you are a consumer or patient please visit this version.

  • Active ingredient

    Magnesium citrate 1.745g per fl oz

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  • Purpose

    Saline laxative

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  • Use

    Use for releif of occasional constipatino (irregularity). Generally produces bowel movement in 1/2 to 6 hours

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  • Warnings

    Warnings

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  • Ask a Doctor

    Ask a doctor before use if you have

    • kidney disease
    • a magnesium-restricted diet
    • abdominal pain, nausea, or vomiting
    • noticed a sudden change in bowel habits that persists over a period of 2 weeks
    • already used a laxative for a period longer than 1 week
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  • Ask a doctor or pharmacist before use

    Ask a doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

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  • Stop use and ask a doctor if

    Stop use and ask a doctor if you have rectal bleeding or railure to have a bowel movement after use. These could be signs of a serious condition.

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  • If pregnant or breast-feeding

    If Pregnant or breast-feeding, ask a help professional before use.

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  • Keep out of reach of children

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    Directions

    • drink a full glass (8 ounces) of liquid with each dose
    • may be taken as a single daily dose or in divided doses

    Adults and children 12 years of age and over - 6.5 to 10 fl oz maximum 10 fl oz in 24 hours

    children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 24 hours

    children 2 to under 6 years of age - 2 to 3 fl oz maximum 3 fl oz in 24 hours

    children under 2 years of age - ask a doctor

    discard unused product within 24 hours of opening bottle

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  • Other information

    Other information

    • magnesium content 290 mg per 1 fl os (30 mL)
    • sodium content 3 mg per 1 fl oz (30 mL)
    • potassium content 84 mg per 1 fl oz (30 mL)
    • store at temperatures between 46º and 86º F (8º and 30º C)
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  • Inactive ingredients

    Inactive ingredients citric acid, flavor, potassium bicarbonate, sodium saccharin, water

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  • Questions

    Questions? Call: 1-888-287-1915

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  • Adverse Reactions

    Distributed by: Wal-Mart Stores, Inc, Bentonville, AR 72716

    Wal-Mart Stores, Inc

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  • Principal display panel

    Do not use if tamper evident twist-off cap is missing, broken or separated from neckring

    Sugar Free/Low sodium

    Magnsium

    Citrate

    U.S.P. Oral Solution

    Saline Laxative

    • Relief of occasionl constipation
    • Bowel cleansing for surgery or exam preparation
    • Pasteurized
    • Alcohol Content 0.031% (from flavoring)
    • 10 FL OZ (296 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    CITROMA 
    magnesium citrate liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-380
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM CITRATE (MAGNESIUM CATION) MAGNESIUM CATION 1.745 g  in 29.6 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    POTASSIUM BICARBONATE  
    SACCHARIN  
    water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-380-38 296 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part334 04/13/2012
    Labeler - Wal-Mart Stores Inc (051957769)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(49035-380)
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